Beriplast P Combiset powder and solvent for solution for injection
Marketed by Dexa Medica
Ingredients in every vial
|Fibrinogen concentrate for Beriplast P (lyophilized powder)||174 mg|
|Aprotinin solution for Beriplast P (diluent)||1 ml|
|Human thrombin for Beriplast P (lyophilized powder)||7.6 mg|
|Calcium chloride solution for Beriplast P (diluent)||1 ml|
Each package contains
|ATC Level 1||B - Blood and blood forming organs|
|ATC Level 2||B02 - Antihemorrhagics|
|ATC Level 3||B02B - Vitamin K and Other Hemostatics|
0 TO 18 YEARS OLD
The safety and efficacy of Beriplast in children and adolescents has not yet been established in controlled clinical studies
18 YEARS OLD AND ABOVE
The volume of Beriplast to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Application of the product must be individualised by the treating physician. In clinical trials, the individual dosages have typically ranged from 0.5 to 4 ml. For some procedures (e.g. liver traumata, or the sealing of large burned surfaces) larger volumes (10 ml or more) may be required.
The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary.
Supportive treatment where standard surgical techniques are insufficient
– for improvement of haemostasis
– as a tissue glue to promote adhesion/sealing or as suture support